CompletedNCT01641237Updated Jul 24, 2014Results posted

Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions

A Phase 3 interventional study of sodium fluoride and no added fluoride in a silica base in Enamel Erosion, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-24.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.

Conditions studied

Enamel Erosion

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Inclusion Criteria:

intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 72 participants (actual)

Study arms

Experimental
Low ppm fluoride dentifrice
Low ppm fluoride as sodium fluoride in a silica base dentifrice
Drug: sodium fluoride
Experimental
Medium ppm fluoride dentifrice
Medium ppm fluoride as sodium fluoride in a silica base dentifrice
Drug: sodium fluoride
Experimental
High ppm fluoride dentifrice
High ppm fluoride as sodium fluoride in a silica base dentifrice
Drug: sodium fluoride
Placebo comparator
No fluoride dentifrice
no added fluoride in a silica base dentifrice
Drug: no added fluoride in a silica base

Interventions

Drugsodium fluoride
fluoride as sodium fluoride
Drugno added fluoride in a silica base
no added fluoride

What researchers measure

Primary outcomes

Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.
Time frame: Baseline to 4 hours

Secondary outcomes

%SMHR
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.
Time frame: Baseline to 4 hours
Percentage Relative Erosion Resistance
Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100.
Time frame: Baseline to 4 hours
Enamel Fluoride Uptake (Corrected Data)
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.
Time frame: Baseline to 4 hours

Results

Posted Jul 31, 2013

Participant flow

Participants were recruited at the clinical site.

Period I

Participant flow — Period I
Milestone	Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F	NaF Dentifrice (1150ppmF)	NaF Dentifrice (250ppmF)	Placebo Dentifrice (0ppmF)
Started	16	16	15	15
Completed	16	16	15	15
Not completed	0	0	0	0

Period II

Participant flow — Period II
Milestone	Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F	NaF Dentifrice (1150ppmF)	NaF Dentifrice (250ppmF)	Placebo Dentifrice (0ppmF)
Started	15	16	16	15
Completed	14	16	16	15
Not completed	1	0	0	0
Withdrew: Withdrawal by subject	1	0	0	0

Period III

Participant flow — Period III
Milestone	Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F	NaF Dentifrice (1150ppmF)	NaF Dentifrice (250ppmF)	Placebo Dentifrice (0ppmF)
Started	16	14	15	16
Completed	15	14	15	16
Not completed	1	0	0	0
Withdrew: Lost to follow-up	1	0	0	0

Period IV

Participant flow — Period IV
Milestone	Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F	NaF Dentifrice (1150ppmF)	NaF Dentifrice (250ppmF)	Placebo Dentifrice (0ppmF)
Started	15	15	15	15
Completed	15	15	15	15
Not completed	0	0	0	0

Outcome measures

PrimaryPercentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship

SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.

Time frame:: Baseline to 4 hours
Reported as:: Mean · %SMHR

Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship
%SMHR	NaF Dentifrice (1426 ppmF)	NaF Dentifrice (1150 ppmF)	NaF Dentifrice (250 ppmF)	Placebo Dentifrice (0 ppmF)
Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship	30.89 ± 1.38	28.71 ± 1.38	25.28 ± 1.38	21.03 ± 1.39

Statistical analysis

NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (1150 ppmF) vs NaF Dentifrice (250 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.
NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (1150 ppmF) vs NaF Dentifrice (250 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = 0.3748Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.

Secondary%SMHR

Time frame:: Baseline to 4 hours
Reported as:: Mean · %SMHR

%SMHR
%SMHR	NaF Dentifrice (1426 ppmF)	NaF Dentifrice (1150 ppmF)	NaF Dentifrice (250 ppmF)	Placebo Dentifrice (0 ppmF)
%SMHR	30.9 ± 1.38	28.7 ± 1.38	25.3 ± 1.38	21.0 ± 1.39

Statistical analysis

NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (1150 ppmF) · ANOVA · p = 0.1898 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 2.17 · 95% CI -1.09 to 5.43Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (250 ppmF) · ANOVA · p = 0.0009 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 5.60 · 95% CI 2.35 to 8.86Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1150 ppmF) vs NaF Dentifrice (250 ppmF) · ANOVA · p = 0.0389 (No adjustment was required for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 3.43 · 95% CI 0.18 to 6.68Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1426 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 9.86 · 95% CI 6.58 to 13.13Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1150 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 7.68 · 95% CI 4.41 to 10.96Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (250 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = 0.0112 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 4.25 · 95% CI 0.98 to 7.53Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.

SecondaryPercentage Relative Erosion Resistance

Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100.

Time frame:: Baseline to 4 hours
Reported as:: Mean · % Relative Erosion Resistance

Percentage Relative Erosion Resistance
% Relative Erosion Resistance	NaF Dentifrice (1426 ppmF)	NaF Dentifrice (1150 ppmF)	NaF Dentifrice (250 ppmF)	Placebo Dentifrice (0 ppmF)
Percentage Relative Erosion Resistance	-38.83 ± 2.75	-39.75 ± 2.75	-50.40 ± 2.75	-71.21 ± 2.77

Statistical analysis

NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (1150 ppmF) vs NaF Dentifrice (250 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.
NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (1150 ppmF) vs NaF Dentifrice (250 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = 0.0002
NaF Dentifrice (1426 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 32.38 · 95% CI 25.18 to 39.59Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1150 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 31.46 · 95% CI 24.25 to 38.67Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (250 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 20.81 · 95% CI 13.60 to 28.02Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (1150 ppmF) · ANOVA · p = 0.8000 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 0.92 · 95% CI -6.25 to 8.10Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (250 ppmF) · ANOVA · p = 0.0017 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 11.57 · 95% CI 4.40 to 18.74Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1150 ppmF) vs NaF Dentifrice (250 ppmF) · ANOVA · p = 0.0038 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 10.65 · 95% CI 3.48 to 17.81Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.

SecondaryEnamel Fluoride Uptake (Corrected Data)

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.

Time frame:: Baseline to 4 hours
Reported as:: Mean · micrograms*F/centimeters^2

Enamel Fluoride Uptake (Corrected Data)
micrograms*F/centimeters^2	NaF Dentifrice (1426 ppmF)	NaF Dentifrice (1150 ppmF)	NaF Dentifrice (250 ppmF)	Placebo Dentifrice (0 ppmF)
Enamel Fluoride Uptake (Corrected Data)	3.13 ± 0.09	3.07 ± 0.09	2.09 ± 0.09	1.47 ± 0.09

Statistical analysis

NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (1150 ppmF) vs NaF Dentifrice (250 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.
NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (1150 ppmF) vs NaF Dentifrice (250 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = 0.0008Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.
NaF Dentifrice (1426 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 1.66 · 95% CI 1.42 to 1.90Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1150 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 1.60 · 95% CI 1.36 to 1.85Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (250 ppmF) vs Placebo Dentifrice (0 ppmF) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 0.62 · 95% CI 0.38 to 0.86Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (1150 ppmF) · ANOVA · p = 0.6680 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 0.05 · 95% CI -0.19 to 0.29Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1426 ppmF) vs NaF Dentifrice (250 ppmF) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 1.04 · 95% CI 0.80 to 1.28Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
NaF Dentifrice (1150 ppmF) vs NaF Dentifrice (250 ppmF) · ANOVA · p = <0.0001 (No adjustment was required for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 0.99 · 95% CI 0.75 to 1.23Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.

Adverse events

Collected over All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
NaF Dentifrice (1426 ppmF)	—	0/62 (0%)	3/62 (4.8%)
NaF Dentifrice (1150 ppmF)	—	0/61 (0%)	6/61 (9.8%)
NaF Dentifrice (250 ppmF)	—	0/62 (0%)	1/62 (1.6%)
Placebo Dentifrice (0 ppmF)	—	0/60 (0%)	4/60 (6.7%)

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	NaF Dentifrice (1426 ppmF)	NaF Dentifrice (1150 ppmF)	NaF Dentifrice (250 ppmF)	Placebo Dentifrice (0 ppmF)
Mouth UlcerationGastrointestinal disorders	1/62	0/61	0/62	2/60
Sinus HeadacheNervous system disorders	0/62	0/61	0/62	1/60
Sensitivity of teethGastrointestinal disorders	0/62	0/61	0/62	1/60
Tooth AbscessInfections and infestations	0/62	1/61	0/62	0/60
CheilitisGastrointestinal disorders	0/62	1/61	0/62	0/60
Mouth InjuryInjury, poisoning and procedural complications	0/62	1/61	0/62	0/60
Tongue HematomaGastrointestinal disorders	0/62	1/61	0/62	0/60
MyalgiaMusculoskeletal and connective tissue disorders	0/62	1/61	0/62	0/60
HeadacheNervous system disorders	0/62	1/61	0/62	0/60
NasopharyngitisInfections and infestations	1/62	0/61	0/62	0/60

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	All Randomized Participants
Mean	36.7 ± 12.2

Sex: Female, Male
Sex: Female, Male(Participants)	All Randomized Participants
Female	35
Male	27

Study locations

1 site

Indiana University School of Dentistry
Indianapolis, Indiana 46202, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01641237
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Jul 16, 2012
Start date: Mar 2012
Primary completion: May 2012
Completion: May 2012
Results posted: Jul 31, 2013
Last update: Jul 24, 2014

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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